Settings and population
This cost efficiency analysis was carried out as part of the CAST-OFF 2 study, and the stair wedge cluster random contrast test studies compared to 3 to 5 weeks for non-reduced distal fractures for one week. The CAST-OFF 2 study recruited patients from January 2022 to January 2023, and had a 12-month follow-up period, including 11 hospitals (Appendix A) in the Netherlands. This study did not perform a better wrist function in six weeks after fixing plaster cast for one week, but it has been proven to have no need for secondary dislocation or surgical intervention compared to the control group (14). Stair Wedges Cluster Random Control Design is a single direction cross-design where the hospital is converted from fixed to fixed for one week for a week for 3-5 weeks of standard. Low included patients were low, so the original step wedge design was made to optimize the registration of the participants (Table 1).
The included criteria were non -or minimal displacement DRF patients without a fracture reduction or indication of surgical correction. The eligible patients were older with an isolated rain or minimum displacement DRF between 18 and 85 years old, and were published in ED within 72 hours of injury and lived independently and received an appropriate understanding of the Dutch language.
Data on this CEA, including direct medical expenses and indirect medical expenses, was collected next to the cast off 2 -step wedge cluster randomy.
Economic evaluation
The CEA analyzed the cost and cost utility of 3-5 weeks compared to a weekly plaster cast fixation in the separated non-displaceable displacement DRF patients.
The EUROQOL-5 Dimension-5 Level (EQ-5D-5L) health index with a Dutch value set is used to evaluate five dimensions to measure the quality of life and to evaluate the patient’s self-evaluation health scores in mobility, self-management, general activity, inconvenience, anxiety/depression and visual analog scale (15, (15, 16). Quality adjustment life (QALY) was calculated according to the trapezoidal rules. One QALY has a perfect health of a year.
Resource utilization and unit cost
The cost is designated as direct cost and indirect costs. Direct or medical costs included plaster cast, ED visits, outpatient patient clinic follow -up, diagnostic video, additional therapy for complications, hospital hospitalization and general openings, medical nurses, physical therapists, company doctors, social workers and drug use. The cost of each patient was collected through the cost efficiency questionnaire spent at week 1, 6, 6 months and 12 weeks. The cost per unit was determined based on the most recent Dutch guidelines for medical cost calculations and drug prices.17,,,18,,,19,,,2021). If possible, the average cost for hospital treatment costs was used in both academic and surrounding hospitals. Medical consumption was calculated as a adjusted medical consumption questionnaire 22. The direct cost is calculated by the cost calculation manual (2016/2024) of the Dutch National Health Care Institute (2016/2024) and has been indexed for 2022 (23). Since 2022 cannot use cross prices, the price of 2023 was used (24).
Indirect or social costs were estimated to be due to productivity loss or decrease due to fracture related at work. The work member was calculated as a questionnaire in 1 week, 6, 6 months, and 12 weeks using the adjusted productivity cost questionnaire 22. Abbreviation and work were multiplied by the average cost per time for losses (21). The costs related to the absence before the work before the injury were not considered as the sum of the total cost. The unit cost calculation is shown in Table 2.
Statistical analysis
Economic health care analysis was performed with analyzed treatment protocols. Data on hospital treatment utility has been extracted from local electronics records. Other medical expenses and productivity losses were calculated as the patient’s questionnaire. The number of utility used for the average cost per patient of available measurements is multiplied. The total cost per patient was calculated as the sum of all costs made during the 12 -month follow -up period. In the early stages, we had a complete case analysis with multiple confrontation analysis to deal with data missing with incomplete subsequent questionnaire. The future virtual scenario was analyzed as one ED visitor, and only one outpatient clinic room visited instead of visiting the outpatient clinic room. This future virtual scenario will evaluate the fact that the patient’s standard management is implemented for one week of plaster cast.
CEA results and QALYS had to be adjusted for clustering in a systematic different observation period (included as a fixed effect in the statistical model) due to the stair wedge design. In addition, a series of joint modifications were included as a fixed effect (age, gender and dominant hand fracture). Assuming that it was completely omitted to explain the value of the decision, multiple confrontation was applied. Cost efficiency plane (CE-plane) and cost-efficiency acceptance curve (CEAC) were inferred from the statistical model described above using the reffects (application of STATA 18), which calculates the best linear prejudice prediction of random effects (model). Since then, these costs and predictions of QALY have booted a boot strap (1000 sample) in a pair.
The boot straping results were visualized on the CE plane and classified the cost differences to four quadrante for the difference between QALYS. In the upper right corner, the intervention is more expensive and more effective, more expensive and less effective in the upper left quadrant, the lower left quadrant is cheaper, less effective, and the lower right quadrant is cheaper and more effective. The CEAC was created to visualize the uncertainty over the cost efficiency of the cast for a week with the value of another payment.
The results of the results are presented with statistical parameters including standard deviation (SD), trust section (CI), and P-values and are analyzed as an independent T-test. In order to solve the potential confusion factors, the linear mixed model was used with random effects on the cluster and the fixed effect of the cluster in consideration of the cluster effect introduced by the hospital. We have adjusted the analysis on the secular trend of the existence of the staircase wedge design, age, gender and fractured hands.
In this study, the original staired wedge design included 11 hospitals, 10 clusters and 12 periods (Appendix B). The sample size of 330 patients was calculated as 0.85, ALFA 0.05 and 0.01 of correlation (ICC) in the cluster. The result of the cast -off test was used in the reference value 5. In the case of CAST-OFF 2, the first result was a wrist evaluation score of the patient level after 6 weeks. PRWE uses multiple lower scale at 0-10 points with a total score of 100 to measure wrist pain and disability in everyday activities. The higher the overall results, the worse the functional results (25). In the case of the control group, the PRWE score 35 and 25 in the intervention group were used to calculate the sample size. Related clinical differences 26 require about 11 points. As can be seen in the Castoff Test, the sample size of 440 patients was calculated to explain 30% loss of subsequent measures. In other words, four patients per cluster per month.
The statistical analysis was performed in IBM SPSS, version 27.0.1.0 and STATA version 18.
